Advancing Medical Device Safety Through Proven Software Reliability
How TrustInSoft Analyzer Can Help Medtronic Deliver Safe, Compliant, and Innovative Healthcare Solutions
Ensuring Memory Safety, Zero False Positives, and Standards Compliance
Built For FDA Standards
Accessible to both developers and testers, TrustInSoft also delivers statement and branch coverage, supporting FDA-referenced best practices for safety and security.
Near Zero False Positives
Faster debugging, more efficient validation, and accelerated development cycles mean your team delivers high-quality code to market sooner.
Beyond Traditional Testing Limits
TrustInSoft provides complete certainty for runtime errors (no false negatives), delivering verifiable results that meet FDA expectations for thorough validation.
Guarantee Patient Safety at the Software Level
The FDA’s General Principles of Software Validation notes that testing alone is often insufficient for confidence in safety. TrustInSoft Analyzer goes beyond traditional testing by mathematically proving the absence of runtime errors such as memory corruption and overflows, across all possible input combinations, not just sampled tests. This near zero false positive capability ensures that Medtronic’s embedded systems meet the highest safety benchmarks from the very first release.
Achieve Regulatory Compliance with Confidence
Medical device software must meet stringent standards like IEC 62304, ISO 14971, and FDA guidance on both software validation and cybersecurity in medical devices. TrustInSoft Analyzer provides formal, verifiable proof aligned with these frameworks, covering statement and branch coverage requirements cited by the FDA. Its exhaustive range analysis detects defects and vulnerabilities that could emerge from malformed or unexpected inputs, directly supporting FDA cybersecurity testing requirements.
Accelerate Innovation Without Compromising Safety
The FDA warns that software changes can introduce new risks, even outside the modified area. TrustInSoft integrates into Medtronic’s CI/CD pipeline as a gating mechanism, blocking unsafe changes before they enter production. With rapid, low–false-positive analysis, engineering teams can innovate in robotics, implantables, and connected health platforms while guaranteeing that safety, security, and compliance remain intact.
Formal Verification Services Value Delivered
Accelerate Time to Market
Extend your team with in-house formal methods expertise
Reduce Risk
Find vulnerabilities that typical analysis tools miss
Increase ROI
Improve software security and efficiency.
